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Laminate Medical's fistula support device gets IDE from FDA

The FDA has given Laminate Medical Technologies investigational device exemption approval to conduct a 13-site, 129-patient trial of the VasQ implanted blood vessel external support device, which is intended for patients who need arteriovenous fistulas for dialysis. The trial will assess the primary patency rate at 6 months after the procedure, and patients will be followed as long as two years.

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